Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen

Oral Lichen Planus Clinical Trial

— RALIB  

Official title:

Efficacy of Topical Rapamycin in Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Topical Steroids

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01061853
• Other study ID #: PHRN06-LV/RALIB
• Secondary ID: 2007-000152-14
• Status: Terminated
• Phase: Phase 3
• First received: February 2, 2010
• Last updated: October 15, 2013
• Start date: February 2008
• Est. completion date: November 2012

Study information

• Verified date: October 2013
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine wether topical rapamycin is more efficient than topical steroids in the treatment of chronic erosive lichen planus.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 76
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Oral Lichen Planus

• Oral Erosive Area More Than 1cm²

• Lichen Planus Pathologically Proven

Exclusion Criteria:

• No Previous Treatment by Rapamycin

• Non Child Bearing Or Breast Feeding Woman

• Patient Who Cannot Be Treated By Rapamycin Or Betamethasone

• Chronic Renal Insufficiency (Creatinin Clearance < 40ml/Mn)

• Ongoing Treatment By Topical Calcineurin Inhibitors Or Systemic Steroids Or Retinoids Or Systemic Immunosuppressors Or Thalidomide Or Griseofulvin Or Antimalarials

• Cholesterolemia >7.8 Mmol/L Or Hypertriglyceridemia >3.95mmol/L Non Responsive To Medical Treatments

• Leucopenia (<3000/Mm3)

• Thrombopenia (<100 000/Mm3)

• Hypertransaminasemia (>3n)

• Hypersensitivity To Macrolides

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• TOPICAL SIROLIMUS (RAPAMUNE*)
APPLICATION ON THE LESIONS OF TOPICAL SIROLIMUS (RAPAMUNE*)1mg/ml bid during 3 months
• TOPICAL BETAMETHASONE 0.05%
APPLICATION ON THE LESIONS OF TOPICAL BETAMETHASONE (DIPROLENE*)0.05% bid during 3 months

Locations

Country	Name	City	State
France	Hospital Avicenne-APHP	Bobigny
France	University Hospital of Bordeaux-St.André	Bordeaux
France	University Hospital of Lille	Lille
France	University Hospital of Nice	Nice
France	Hospital La Pitié-Salpêtrière APHP	Paris
France	Hospital Saint Louis-APHP	Paris
France	Hospital Tenon-APHP	Paris
France	University Hospital of REIMS	Reims	Marne
France	University hospital of Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COMPLETE CLEARING OF ORAL EROSIVE LESIONS		THREE MONTHS	No
Secondary	REGRESSION OF EROSIVE SURFACE AREA		THREE MONTHS	No